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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE PERIPHERAL IV CATHETER WINGED GREY INTRAVENOUS CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE PERIPHERAL IV CATHETER WINGED GREY INTRAVENOUS CATHETER Back to Search Results
Catalog Number 381357
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/28/2018
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 5174083; medical device expiration date: 06/30/2020; device manufacture date: 07/28/2015 ; medical device lot #: 4205157; medical device expiration date: 07/31/2019; device manufacture date: 08/22/2014. Investigation summary: our quality engineer inspected the returned unit and confirmed the reported observation. The source of the defect could not be determined. There was an indication of adhesive transferred from the top web to the bottom web on the opened seal area which was present on all the returned sample and thus, showed that the sealing process was completed in the manufacturing facility. A device history record review showed no non-conformances associated with this issue during the production of the reported batches. Customer complaint trends are evaluated on a monthly basis. If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time. Investigation conclusion: 10 actual samples in opened packaging, from 3 different batches, were returned for investigation. Refer to figure 1. The details are as below: (b)(6). Batch number 5174083; batch number 4205157; batch number 4314498. Actual samples: the actual samples were subjected to visual inspection. Opened seal was observed on all the returned samples. Refer to figure 2. Batch 5174083; batch 4205157; batch 4314498; opened seal; opened seal was observed on all the returned samples. Root cause description: there is an indication of adhesive transferred from the top web to the bottom web on the opened seal area, refer to figure 3, which was present on all the returned sample and thus, showed that the sealing process was completed in manufacturing facility. Batch 5174083; batch 4205157; batch 4314498; figure 3: indication of adhesive transfer therefore, no assignable root cause can be established. Rationale: there is an indication of adhesive transferred from the top web to the bottom web on the opened seal area which was present on all the returned sample and thus, showed that the sealing process was completed in the manufacturing facility.
 
Event Description
It was reported that the bd insyte peripheral iv catheter winged grey product was partly detached prior to use. No reports of serious injury or medical intervention noted.
 
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Brand NameBD INSYTE PERIPHERAL IV CATHETER WINGED GREY
Type of DeviceINTRAVENOUS CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7485417
MDR Text Key107995687
Report Number8041187-2018-00136
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903812677
UDI-Public00382903812677
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Pharmacist
Device Catalogue Number381357
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/01/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/03/2018 Patient Sequence Number: 1
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